User login
Ramucirumab effective in patients with advanced HCC and AFP ≥400 ng/mL after non-sorafenib therapies
Key clinical point: Ramucirumab offers clinically significant efficacy with no new safety signals after non-sorafenib systemic therapies in patients with advanced hepatocellular carcinoma (HCC) and alpha-fetoprotein (AFP) ≥400 ng/mL.
Major finding: Median overall and progression-free survival were 8.7 (95% CI 4.6-12.2) months and 1.7 (95% CI 1.5-4.1) months, respectively. The objective response rate was 10.6% (95% CI 1.8%-19.5%), and the disease control rate was 46.8% (95% CI 32.5%-61.1%). The grade ≥3 adverse event (AE) rate was 57%, with hypertension (11%) being the most frequent AE.
Study details: This open-label, non-comparative cohort of the REACH-2 study included 47 patients with advanced HCC and baseline AFP ≥400 ng/mL who had received non-sorafenib-based systemic therapies.
Disclosures: This study was funded by Eli Lilly and Company, U.S. Some authors declared serving as consultants or advisors for or receiving research funding or honoraria from various sources, including Eli Lilly. Four authors declared being employees of Eli Lilly.
Source: Finn RS et al. Ramucirumab for patients with advanced hepatocellular carcinoma and elevated alpha fetoprotein following non-sorafenib systemic therapy: An expansion cohort of REACH-2. Oncologist. 2022 (Oct 3). Doi: 10.1093/oncolo/oyac183
Key clinical point: Ramucirumab offers clinically significant efficacy with no new safety signals after non-sorafenib systemic therapies in patients with advanced hepatocellular carcinoma (HCC) and alpha-fetoprotein (AFP) ≥400 ng/mL.
Major finding: Median overall and progression-free survival were 8.7 (95% CI 4.6-12.2) months and 1.7 (95% CI 1.5-4.1) months, respectively. The objective response rate was 10.6% (95% CI 1.8%-19.5%), and the disease control rate was 46.8% (95% CI 32.5%-61.1%). The grade ≥3 adverse event (AE) rate was 57%, with hypertension (11%) being the most frequent AE.
Study details: This open-label, non-comparative cohort of the REACH-2 study included 47 patients with advanced HCC and baseline AFP ≥400 ng/mL who had received non-sorafenib-based systemic therapies.
Disclosures: This study was funded by Eli Lilly and Company, U.S. Some authors declared serving as consultants or advisors for or receiving research funding or honoraria from various sources, including Eli Lilly. Four authors declared being employees of Eli Lilly.
Source: Finn RS et al. Ramucirumab for patients with advanced hepatocellular carcinoma and elevated alpha fetoprotein following non-sorafenib systemic therapy: An expansion cohort of REACH-2. Oncologist. 2022 (Oct 3). Doi: 10.1093/oncolo/oyac183
Key clinical point: Ramucirumab offers clinically significant efficacy with no new safety signals after non-sorafenib systemic therapies in patients with advanced hepatocellular carcinoma (HCC) and alpha-fetoprotein (AFP) ≥400 ng/mL.
Major finding: Median overall and progression-free survival were 8.7 (95% CI 4.6-12.2) months and 1.7 (95% CI 1.5-4.1) months, respectively. The objective response rate was 10.6% (95% CI 1.8%-19.5%), and the disease control rate was 46.8% (95% CI 32.5%-61.1%). The grade ≥3 adverse event (AE) rate was 57%, with hypertension (11%) being the most frequent AE.
Study details: This open-label, non-comparative cohort of the REACH-2 study included 47 patients with advanced HCC and baseline AFP ≥400 ng/mL who had received non-sorafenib-based systemic therapies.
Disclosures: This study was funded by Eli Lilly and Company, U.S. Some authors declared serving as consultants or advisors for or receiving research funding or honoraria from various sources, including Eli Lilly. Four authors declared being employees of Eli Lilly.
Source: Finn RS et al. Ramucirumab for patients with advanced hepatocellular carcinoma and elevated alpha fetoprotein following non-sorafenib systemic therapy: An expansion cohort of REACH-2. Oncologist. 2022 (Oct 3). Doi: 10.1093/oncolo/oyac183
Unresectable HCC: Atezolizumab plus bevacizumab proves its worth in the clinic
Key clinical point: The efficacy and safety profile of atezolizumab plus bevacizumab for unresectable hepatocellular carcinoma (HCC) in routine clinical practice is similar to that reported in the phase 3 IMbrave150 study.
Major finding: After a median follow-up of 10.0 months, the median overall survival was 15.7 months (95% CI 14.50-not estimated) and the progression-free survival was 6.9 months (95% CI 6.10-8.30). Among response-evaluable patients (n = 273), 30.8% achieved an objective response. Grade 3/4 treatment-related adverse events occurred in 23.6% of patients.
Study details: This multicenter prospective observational study, AB-Real, included 296 patients who received first-line atezolizumab plus bevacizumab for unresectable HCC.
Disclosures: This study received no specific funding. Some authors declared serving as consultants, advisors, or receiving lecture fees, advisory board honoraria, research grants, or travel or accommodation expenses from various sources.
Source: Fulgenzi CAM et al. Reproducible safety and efficacy of atezolizumab plus bevacizumab for HCC in clinical practice: Results of the AB-real study. Eur J Cancer. 2022;175:204-213 (Sep 20). Doi: 10.1016/j.ejca.2022.08.024
Key clinical point: The efficacy and safety profile of atezolizumab plus bevacizumab for unresectable hepatocellular carcinoma (HCC) in routine clinical practice is similar to that reported in the phase 3 IMbrave150 study.
Major finding: After a median follow-up of 10.0 months, the median overall survival was 15.7 months (95% CI 14.50-not estimated) and the progression-free survival was 6.9 months (95% CI 6.10-8.30). Among response-evaluable patients (n = 273), 30.8% achieved an objective response. Grade 3/4 treatment-related adverse events occurred in 23.6% of patients.
Study details: This multicenter prospective observational study, AB-Real, included 296 patients who received first-line atezolizumab plus bevacizumab for unresectable HCC.
Disclosures: This study received no specific funding. Some authors declared serving as consultants, advisors, or receiving lecture fees, advisory board honoraria, research grants, or travel or accommodation expenses from various sources.
Source: Fulgenzi CAM et al. Reproducible safety and efficacy of atezolizumab plus bevacizumab for HCC in clinical practice: Results of the AB-real study. Eur J Cancer. 2022;175:204-213 (Sep 20). Doi: 10.1016/j.ejca.2022.08.024
Key clinical point: The efficacy and safety profile of atezolizumab plus bevacizumab for unresectable hepatocellular carcinoma (HCC) in routine clinical practice is similar to that reported in the phase 3 IMbrave150 study.
Major finding: After a median follow-up of 10.0 months, the median overall survival was 15.7 months (95% CI 14.50-not estimated) and the progression-free survival was 6.9 months (95% CI 6.10-8.30). Among response-evaluable patients (n = 273), 30.8% achieved an objective response. Grade 3/4 treatment-related adverse events occurred in 23.6% of patients.
Study details: This multicenter prospective observational study, AB-Real, included 296 patients who received first-line atezolizumab plus bevacizumab for unresectable HCC.
Disclosures: This study received no specific funding. Some authors declared serving as consultants, advisors, or receiving lecture fees, advisory board honoraria, research grants, or travel or accommodation expenses from various sources.
Source: Fulgenzi CAM et al. Reproducible safety and efficacy of atezolizumab plus bevacizumab for HCC in clinical practice: Results of the AB-real study. Eur J Cancer. 2022;175:204-213 (Sep 20). Doi: 10.1016/j.ejca.2022.08.024
Commentary: Evaluating HCC Treatments, October 2022
Patients with hepatocellular carcinoma (HCC) may benefit from liver-directed therapies or palliative systemic therapies. This month we will review articles that address management of patients who were treated with different standard treatment options.
Komatsu and colleagues performed a case-matched analysis to evaluate the best first-line treatment for HCC in patients with macroscopic portal vein tumor thrombus (PVTT). Patients had advanced HCC and macroscopic PVTT that invaded an ipsilateral first-order portal branch, main trunk, or contralateral portal vein. The propensity score–matched groups underwent either hepatectomy (n = 36) or received sorafenib (n = 36). To be considered for resection, patients had to have Child-Pugh (CP) grade A or B liver function, an Eastern Cooperative Oncology Group Performance Status score of ≤ 1, life expectancy of > 3 months, and the macroscopic resection of the targeted tumor could be planned with an estimated remnant liver volume ≥ 35%.
Out of 36 patients who underwent surgery, 23 underwent reductive hepatectomy, and 13 underwent complete resection of tumor. Out of 36 patients who received sorafenib, 21 underwent subsequent treatments. The median overall survival (OS) of patients who underwent hepatectomy was 15.1 months, significantly longer than the 4.5 months for patients who were treated with sorafenib. The authors concluded that selected patients who underwent tumor resection lived longer than patients who received systemic therapy with sorafenib first, despite the presence of macroscopic PVTT.
Lenvatinib is an approved treatment for patients with HCC. Because most patients with HCC have underlying cirrhosis, monitoring the underlying liver function is an important facet of patient management. Huynh and colleagues reported on patients in the REFLECT trial whose liver function deteriorated from CP-A to CP-B while receiving systemic therapy. This post hoc analysis included patients whose liver function deteriorated to CP-B or remained CP-A within 8 weeks of randomization to lenvatinib (CP-B: n = 60; CP-A: n = 413) or sorafenib (CP-B: n = 47; CP-A: n = 427). Patients receiving lenvatinib who developed CP-B cirrhosis compared with patients who maintained CP-A cirrhosis had a median progression-free survival (PFS) of 3.7 months (95% CI 1.8-7.4) vs 6.5 months (95% CI 5.6-7.4) and OS of 6.8 months (95% CI 2.6-10.3) vs 13.3 months (95% CI 11.6-16.1). CP-B patients receiving sorafenib had a median PFS and OS of only 0.5 months (95% CI 0.1-3.6) and 4.5 months (95% CI 2.9-6.1), respectively. No new safety signals were reported in CP-B patients. The investigators concluded that deterioration of liver function to CP-B does not require the discontinuation of lenvatinib therapy.
Finally, Brown and colleagues performed a meta-analysis of studies that evaluated transarterial radioembolization (TARE) and transarterial chemoembolization (TACE) in patients with HCC by reviewing 17 studies involving 2465 patients that directly compared TACE and TARE. TARE significantly prolonged the mean time to progression (17.5 vs 9.8 months; 95% CI 1.3-8.3 months) but resulted in comparable OS (absolute difference −0.55 months; 95% CI −1.95 to 3.05 months). Safety profiles appeared to favor TARE. The authors concluded that TACE and TARE should be compared in larger prospective studies to better compare survival, progression, and safety data.
Patients with hepatocellular carcinoma (HCC) may benefit from liver-directed therapies or palliative systemic therapies. This month we will review articles that address management of patients who were treated with different standard treatment options.
Komatsu and colleagues performed a case-matched analysis to evaluate the best first-line treatment for HCC in patients with macroscopic portal vein tumor thrombus (PVTT). Patients had advanced HCC and macroscopic PVTT that invaded an ipsilateral first-order portal branch, main trunk, or contralateral portal vein. The propensity score–matched groups underwent either hepatectomy (n = 36) or received sorafenib (n = 36). To be considered for resection, patients had to have Child-Pugh (CP) grade A or B liver function, an Eastern Cooperative Oncology Group Performance Status score of ≤ 1, life expectancy of > 3 months, and the macroscopic resection of the targeted tumor could be planned with an estimated remnant liver volume ≥ 35%.
Out of 36 patients who underwent surgery, 23 underwent reductive hepatectomy, and 13 underwent complete resection of tumor. Out of 36 patients who received sorafenib, 21 underwent subsequent treatments. The median overall survival (OS) of patients who underwent hepatectomy was 15.1 months, significantly longer than the 4.5 months for patients who were treated with sorafenib. The authors concluded that selected patients who underwent tumor resection lived longer than patients who received systemic therapy with sorafenib first, despite the presence of macroscopic PVTT.
Lenvatinib is an approved treatment for patients with HCC. Because most patients with HCC have underlying cirrhosis, monitoring the underlying liver function is an important facet of patient management. Huynh and colleagues reported on patients in the REFLECT trial whose liver function deteriorated from CP-A to CP-B while receiving systemic therapy. This post hoc analysis included patients whose liver function deteriorated to CP-B or remained CP-A within 8 weeks of randomization to lenvatinib (CP-B: n = 60; CP-A: n = 413) or sorafenib (CP-B: n = 47; CP-A: n = 427). Patients receiving lenvatinib who developed CP-B cirrhosis compared with patients who maintained CP-A cirrhosis had a median progression-free survival (PFS) of 3.7 months (95% CI 1.8-7.4) vs 6.5 months (95% CI 5.6-7.4) and OS of 6.8 months (95% CI 2.6-10.3) vs 13.3 months (95% CI 11.6-16.1). CP-B patients receiving sorafenib had a median PFS and OS of only 0.5 months (95% CI 0.1-3.6) and 4.5 months (95% CI 2.9-6.1), respectively. No new safety signals were reported in CP-B patients. The investigators concluded that deterioration of liver function to CP-B does not require the discontinuation of lenvatinib therapy.
Finally, Brown and colleagues performed a meta-analysis of studies that evaluated transarterial radioembolization (TARE) and transarterial chemoembolization (TACE) in patients with HCC by reviewing 17 studies involving 2465 patients that directly compared TACE and TARE. TARE significantly prolonged the mean time to progression (17.5 vs 9.8 months; 95% CI 1.3-8.3 months) but resulted in comparable OS (absolute difference −0.55 months; 95% CI −1.95 to 3.05 months). Safety profiles appeared to favor TARE. The authors concluded that TACE and TARE should be compared in larger prospective studies to better compare survival, progression, and safety data.
Patients with hepatocellular carcinoma (HCC) may benefit from liver-directed therapies or palliative systemic therapies. This month we will review articles that address management of patients who were treated with different standard treatment options.
Komatsu and colleagues performed a case-matched analysis to evaluate the best first-line treatment for HCC in patients with macroscopic portal vein tumor thrombus (PVTT). Patients had advanced HCC and macroscopic PVTT that invaded an ipsilateral first-order portal branch, main trunk, or contralateral portal vein. The propensity score–matched groups underwent either hepatectomy (n = 36) or received sorafenib (n = 36). To be considered for resection, patients had to have Child-Pugh (CP) grade A or B liver function, an Eastern Cooperative Oncology Group Performance Status score of ≤ 1, life expectancy of > 3 months, and the macroscopic resection of the targeted tumor could be planned with an estimated remnant liver volume ≥ 35%.
Out of 36 patients who underwent surgery, 23 underwent reductive hepatectomy, and 13 underwent complete resection of tumor. Out of 36 patients who received sorafenib, 21 underwent subsequent treatments. The median overall survival (OS) of patients who underwent hepatectomy was 15.1 months, significantly longer than the 4.5 months for patients who were treated with sorafenib. The authors concluded that selected patients who underwent tumor resection lived longer than patients who received systemic therapy with sorafenib first, despite the presence of macroscopic PVTT.
Lenvatinib is an approved treatment for patients with HCC. Because most patients with HCC have underlying cirrhosis, monitoring the underlying liver function is an important facet of patient management. Huynh and colleagues reported on patients in the REFLECT trial whose liver function deteriorated from CP-A to CP-B while receiving systemic therapy. This post hoc analysis included patients whose liver function deteriorated to CP-B or remained CP-A within 8 weeks of randomization to lenvatinib (CP-B: n = 60; CP-A: n = 413) or sorafenib (CP-B: n = 47; CP-A: n = 427). Patients receiving lenvatinib who developed CP-B cirrhosis compared with patients who maintained CP-A cirrhosis had a median progression-free survival (PFS) of 3.7 months (95% CI 1.8-7.4) vs 6.5 months (95% CI 5.6-7.4) and OS of 6.8 months (95% CI 2.6-10.3) vs 13.3 months (95% CI 11.6-16.1). CP-B patients receiving sorafenib had a median PFS and OS of only 0.5 months (95% CI 0.1-3.6) and 4.5 months (95% CI 2.9-6.1), respectively. No new safety signals were reported in CP-B patients. The investigators concluded that deterioration of liver function to CP-B does not require the discontinuation of lenvatinib therapy.
Finally, Brown and colleagues performed a meta-analysis of studies that evaluated transarterial radioembolization (TARE) and transarterial chemoembolization (TACE) in patients with HCC by reviewing 17 studies involving 2465 patients that directly compared TACE and TARE. TARE significantly prolonged the mean time to progression (17.5 vs 9.8 months; 95% CI 1.3-8.3 months) but resulted in comparable OS (absolute difference −0.55 months; 95% CI −1.95 to 3.05 months). Safety profiles appeared to favor TARE. The authors concluded that TACE and TARE should be compared in larger prospective studies to better compare survival, progression, and safety data.
Commentary: Evaluating HCC Treatments, October 2022
Patients with hepatocellular carcinoma (HCC) may benefit from liver-directed therapies or palliative systemic therapies. This month we will review articles that address management of patients who were treated with different standard treatment options.
Komatsu and colleagues performed a case-matched analysis to evaluate the best first-line treatment for HCC in patients with macroscopic portal vein tumor thrombus (PVTT). Patients had advanced HCC and macroscopic PVTT that invaded an ipsilateral first-order portal branch, main trunk, or contralateral portal vein. The propensity score–matched groups underwent either hepatectomy (n = 36) or received sorafenib (n = 36). To be considered for resection, patients had to have Child-Pugh (CP) grade A or B liver function, an Eastern Cooperative Oncology Group Performance Status score of ≤ 1, life expectancy of > 3 months, and the macroscopic resection of the targeted tumor could be planned with an estimated remnant liver volume ≥ 35%.
Out of 36 patients who underwent surgery, 23 underwent reductive hepatectomy, and 13 underwent complete resection of tumor. Out of 36 patients who received sorafenib, 21 underwent subsequent treatments. The median overall survival (OS) of patients who underwent hepatectomy was 15.1 months, significantly longer than the 4.5 months for patients who were treated with sorafenib. The authors concluded that selected patients who underwent tumor resection lived longer than patients who received systemic therapy with sorafenib first, despite the presence of macroscopic PVTT.
Lenvatinib is an approved treatment for patients with HCC. Because most patients with HCC have underlying cirrhosis, monitoring the underlying liver function is an important facet of patient management. Huynh and colleagues reported on patients in the REFLECT trial whose liver function deteriorated from CP-A to CP-B while receiving systemic therapy. This post hoc analysis included patients whose liver function deteriorated to CP-B or remained CP-A within 8 weeks of randomization to lenvatinib (CP-B: n = 60; CP-A: n = 413) or sorafenib (CP-B: n = 47; CP-A: n = 427). Patients receiving lenvatinib who developed CP-B cirrhosis compared with patients who maintained CP-A cirrhosis had a median progression-free survival (PFS) of 3.7 months (95% CI 1.8-7.4) vs 6.5 months (95% CI 5.6-7.4) and OS of 6.8 months (95% CI 2.6-10.3) vs 13.3 months (95% CI 11.6-16.1). CP-B patients receiving sorafenib had a median PFS and OS of only 0.5 months (95% CI 0.1-3.6) and 4.5 months (95% CI 2.9-6.1), respectively. No new safety signals were reported in CP-B patients. The investigators concluded that deterioration of liver function to CP-B does not require the discontinuation of lenvatinib therapy.
Finally, Brown and colleagues performed a meta-analysis of studies that evaluated transarterial radioembolization (TARE) and transarterial chemoembolization (TACE) in patients with HCC by reviewing 17 studies involving 2465 patients that directly compared TACE and TARE. TARE significantly prolonged the mean time to progression (17.5 vs 9.8 months; 95% CI 1.3-8.3 months) but resulted in comparable OS (absolute difference −0.55 months; 95% CI −1.95 to 3.05 months). Safety profiles appeared to favor TARE. The authors concluded that TACE and TARE should be compared in larger prospective studies to better compare survival, progression, and safety data.
Patients with hepatocellular carcinoma (HCC) may benefit from liver-directed therapies or palliative systemic therapies. This month we will review articles that address management of patients who were treated with different standard treatment options.
Komatsu and colleagues performed a case-matched analysis to evaluate the best first-line treatment for HCC in patients with macroscopic portal vein tumor thrombus (PVTT). Patients had advanced HCC and macroscopic PVTT that invaded an ipsilateral first-order portal branch, main trunk, or contralateral portal vein. The propensity score–matched groups underwent either hepatectomy (n = 36) or received sorafenib (n = 36). To be considered for resection, patients had to have Child-Pugh (CP) grade A or B liver function, an Eastern Cooperative Oncology Group Performance Status score of ≤ 1, life expectancy of > 3 months, and the macroscopic resection of the targeted tumor could be planned with an estimated remnant liver volume ≥ 35%.
Out of 36 patients who underwent surgery, 23 underwent reductive hepatectomy, and 13 underwent complete resection of tumor. Out of 36 patients who received sorafenib, 21 underwent subsequent treatments. The median overall survival (OS) of patients who underwent hepatectomy was 15.1 months, significantly longer than the 4.5 months for patients who were treated with sorafenib. The authors concluded that selected patients who underwent tumor resection lived longer than patients who received systemic therapy with sorafenib first, despite the presence of macroscopic PVTT.
Lenvatinib is an approved treatment for patients with HCC. Because most patients with HCC have underlying cirrhosis, monitoring the underlying liver function is an important facet of patient management. Huynh and colleagues reported on patients in the REFLECT trial whose liver function deteriorated from CP-A to CP-B while receiving systemic therapy. This post hoc analysis included patients whose liver function deteriorated to CP-B or remained CP-A within 8 weeks of randomization to lenvatinib (CP-B: n = 60; CP-A: n = 413) or sorafenib (CP-B: n = 47; CP-A: n = 427). Patients receiving lenvatinib who developed CP-B cirrhosis compared with patients who maintained CP-A cirrhosis had a median progression-free survival (PFS) of 3.7 months (95% CI 1.8-7.4) vs 6.5 months (95% CI 5.6-7.4) and OS of 6.8 months (95% CI 2.6-10.3) vs 13.3 months (95% CI 11.6-16.1). CP-B patients receiving sorafenib had a median PFS and OS of only 0.5 months (95% CI 0.1-3.6) and 4.5 months (95% CI 2.9-6.1), respectively. No new safety signals were reported in CP-B patients. The investigators concluded that deterioration of liver function to CP-B does not require the discontinuation of lenvatinib therapy.
Finally, Brown and colleagues performed a meta-analysis of studies that evaluated transarterial radioembolization (TARE) and transarterial chemoembolization (TACE) in patients with HCC by reviewing 17 studies involving 2465 patients that directly compared TACE and TARE. TARE significantly prolonged the mean time to progression (17.5 vs 9.8 months; 95% CI 1.3-8.3 months) but resulted in comparable OS (absolute difference −0.55 months; 95% CI −1.95 to 3.05 months). Safety profiles appeared to favor TARE. The authors concluded that TACE and TARE should be compared in larger prospective studies to better compare survival, progression, and safety data.
Patients with hepatocellular carcinoma (HCC) may benefit from liver-directed therapies or palliative systemic therapies. This month we will review articles that address management of patients who were treated with different standard treatment options.
Komatsu and colleagues performed a case-matched analysis to evaluate the best first-line treatment for HCC in patients with macroscopic portal vein tumor thrombus (PVTT). Patients had advanced HCC and macroscopic PVTT that invaded an ipsilateral first-order portal branch, main trunk, or contralateral portal vein. The propensity score–matched groups underwent either hepatectomy (n = 36) or received sorafenib (n = 36). To be considered for resection, patients had to have Child-Pugh (CP) grade A or B liver function, an Eastern Cooperative Oncology Group Performance Status score of ≤ 1, life expectancy of > 3 months, and the macroscopic resection of the targeted tumor could be planned with an estimated remnant liver volume ≥ 35%.
Out of 36 patients who underwent surgery, 23 underwent reductive hepatectomy, and 13 underwent complete resection of tumor. Out of 36 patients who received sorafenib, 21 underwent subsequent treatments. The median overall survival (OS) of patients who underwent hepatectomy was 15.1 months, significantly longer than the 4.5 months for patients who were treated with sorafenib. The authors concluded that selected patients who underwent tumor resection lived longer than patients who received systemic therapy with sorafenib first, despite the presence of macroscopic PVTT.
Lenvatinib is an approved treatment for patients with HCC. Because most patients with HCC have underlying cirrhosis, monitoring the underlying liver function is an important facet of patient management. Huynh and colleagues reported on patients in the REFLECT trial whose liver function deteriorated from CP-A to CP-B while receiving systemic therapy. This post hoc analysis included patients whose liver function deteriorated to CP-B or remained CP-A within 8 weeks of randomization to lenvatinib (CP-B: n = 60; CP-A: n = 413) or sorafenib (CP-B: n = 47; CP-A: n = 427). Patients receiving lenvatinib who developed CP-B cirrhosis compared with patients who maintained CP-A cirrhosis had a median progression-free survival (PFS) of 3.7 months (95% CI 1.8-7.4) vs 6.5 months (95% CI 5.6-7.4) and OS of 6.8 months (95% CI 2.6-10.3) vs 13.3 months (95% CI 11.6-16.1). CP-B patients receiving sorafenib had a median PFS and OS of only 0.5 months (95% CI 0.1-3.6) and 4.5 months (95% CI 2.9-6.1), respectively. No new safety signals were reported in CP-B patients. The investigators concluded that deterioration of liver function to CP-B does not require the discontinuation of lenvatinib therapy.
Finally, Brown and colleagues performed a meta-analysis of studies that evaluated transarterial radioembolization (TARE) and transarterial chemoembolization (TACE) in patients with HCC by reviewing 17 studies involving 2465 patients that directly compared TACE and TARE. TARE significantly prolonged the mean time to progression (17.5 vs 9.8 months; 95% CI 1.3-8.3 months) but resulted in comparable OS (absolute difference −0.55 months; 95% CI −1.95 to 3.05 months). Safety profiles appeared to favor TARE. The authors concluded that TACE and TARE should be compared in larger prospective studies to better compare survival, progression, and safety data.
TARE vs TACE prolongs time to progression in HCC but not overall survival
Key clinical point: In patients with hepatocellular carcinoma (HCC), transarterial radioembolization (TARE) provides significantly longer time to progression (TTP) than transarterial chemoembolization (TACE), but does not significantly prolong overall survival.
Major finding: TARE vs TACE significantly prolonged the mean TTP (17.5 vs 9.8 months; 95% CI 1.3-8.3 months) but resulted in comparable overall survival (absolute difference −0.55 months; 95% CI −1.95 to 3.05 months).
Study details: This was a meta-analysis of 17 studies involving 2465 unique patients that directly compared TACE and TARE for treating HCC.
Disclosures: This study was supported by the US National Institutes of Health. Some authors declared serving as consultants or advisory board members of or receiving grants from various sources.
Source: Brown AM et al. TACE versus TARE for patients with hepatocellular carcinoma: Overall and individual patient level meta-analysis. Cancer Med. 2022 (Aug 9). Doi: 10.1002/cam4.5125
Key clinical point: In patients with hepatocellular carcinoma (HCC), transarterial radioembolization (TARE) provides significantly longer time to progression (TTP) than transarterial chemoembolization (TACE), but does not significantly prolong overall survival.
Major finding: TARE vs TACE significantly prolonged the mean TTP (17.5 vs 9.8 months; 95% CI 1.3-8.3 months) but resulted in comparable overall survival (absolute difference −0.55 months; 95% CI −1.95 to 3.05 months).
Study details: This was a meta-analysis of 17 studies involving 2465 unique patients that directly compared TACE and TARE for treating HCC.
Disclosures: This study was supported by the US National Institutes of Health. Some authors declared serving as consultants or advisory board members of or receiving grants from various sources.
Source: Brown AM et al. TACE versus TARE for patients with hepatocellular carcinoma: Overall and individual patient level meta-analysis. Cancer Med. 2022 (Aug 9). Doi: 10.1002/cam4.5125
Key clinical point: In patients with hepatocellular carcinoma (HCC), transarterial radioembolization (TARE) provides significantly longer time to progression (TTP) than transarterial chemoembolization (TACE), but does not significantly prolong overall survival.
Major finding: TARE vs TACE significantly prolonged the mean TTP (17.5 vs 9.8 months; 95% CI 1.3-8.3 months) but resulted in comparable overall survival (absolute difference −0.55 months; 95% CI −1.95 to 3.05 months).
Study details: This was a meta-analysis of 17 studies involving 2465 unique patients that directly compared TACE and TARE for treating HCC.
Disclosures: This study was supported by the US National Institutes of Health. Some authors declared serving as consultants or advisory board members of or receiving grants from various sources.
Source: Brown AM et al. TACE versus TARE for patients with hepatocellular carcinoma: Overall and individual patient level meta-analysis. Cancer Med. 2022 (Aug 9). Doi: 10.1002/cam4.5125
Baseline DCP levels and NLR predict survival in patients receiving atezolizumab+bevacizumab for advanced HCC
Key clinical point: Baseline des-gamma-carboxy prothrombin (DCP) levels and neutrophil-to-lymphocyte ratio (NLR) may serve as predictive biomarkers of survival in patients with advanced hepatocellular carcinoma (HCC) receiving atezolizumab plus bevacizumab (ATE+BEV) therapy.
Major finding: Multivariate analysis revealed that a DCP level of ≥186 mAU/mL and an NLR of ≥2.5 independently predict overall survival (adjusted hazard ratio [aHR] 5.102; P < .001; and aHR 3.584; P = .001, respectively) and progression-free survival (aHR 2.311; P = .002; and aHR 1.938; P = .012, respectively).
Study details: The data come from a real-world observational study that included 121 patients with advanced HCC who received ≥1 cycle of ATE+BEV treatment.
Disclosures: This study was sponsored by a National Research Foundation of Korea grant funded by the Korea government. Some authors declared receiving honoraria or research grants from various sources.
Source: Chon YE, Cheon J, et al. Predictive biomarkers of survival in patients with advanced hepatocellular carcinoma receiving atezolizumab plus bevacizumab treatment. Cancer Med. 2022 (Aug 23). Doi: 10.1002/cam4.5161
Key clinical point: Baseline des-gamma-carboxy prothrombin (DCP) levels and neutrophil-to-lymphocyte ratio (NLR) may serve as predictive biomarkers of survival in patients with advanced hepatocellular carcinoma (HCC) receiving atezolizumab plus bevacizumab (ATE+BEV) therapy.
Major finding: Multivariate analysis revealed that a DCP level of ≥186 mAU/mL and an NLR of ≥2.5 independently predict overall survival (adjusted hazard ratio [aHR] 5.102; P < .001; and aHR 3.584; P = .001, respectively) and progression-free survival (aHR 2.311; P = .002; and aHR 1.938; P = .012, respectively).
Study details: The data come from a real-world observational study that included 121 patients with advanced HCC who received ≥1 cycle of ATE+BEV treatment.
Disclosures: This study was sponsored by a National Research Foundation of Korea grant funded by the Korea government. Some authors declared receiving honoraria or research grants from various sources.
Source: Chon YE, Cheon J, et al. Predictive biomarkers of survival in patients with advanced hepatocellular carcinoma receiving atezolizumab plus bevacizumab treatment. Cancer Med. 2022 (Aug 23). Doi: 10.1002/cam4.5161
Key clinical point: Baseline des-gamma-carboxy prothrombin (DCP) levels and neutrophil-to-lymphocyte ratio (NLR) may serve as predictive biomarkers of survival in patients with advanced hepatocellular carcinoma (HCC) receiving atezolizumab plus bevacizumab (ATE+BEV) therapy.
Major finding: Multivariate analysis revealed that a DCP level of ≥186 mAU/mL and an NLR of ≥2.5 independently predict overall survival (adjusted hazard ratio [aHR] 5.102; P < .001; and aHR 3.584; P = .001, respectively) and progression-free survival (aHR 2.311; P = .002; and aHR 1.938; P = .012, respectively).
Study details: The data come from a real-world observational study that included 121 patients with advanced HCC who received ≥1 cycle of ATE+BEV treatment.
Disclosures: This study was sponsored by a National Research Foundation of Korea grant funded by the Korea government. Some authors declared receiving honoraria or research grants from various sources.
Source: Chon YE, Cheon J, et al. Predictive biomarkers of survival in patients with advanced hepatocellular carcinoma receiving atezolizumab plus bevacizumab treatment. Cancer Med. 2022 (Aug 23). Doi: 10.1002/cam4.5161
First-line lenvatinib+toripalimab+FOLFOX-HAIC shows promise in high-risk advanced HCC
Key clinical point: First-line lenvatinib, toripalimab, and hepatic arterial infusion chemotherapy (HAIC) with oxaliplatin, leucovorin, and 5-fluorouracil (FOLFOX) is a well-tolerated and effective treatment for patients with high-risk advanced hepatocellular carcinoma (HCC).
Major finding: The progression-free survival (PFS) of 80.6% (95% CI 64.0%-91.8%) of patients was >6 months, and the median PFS was 10.4 months (95% CI 5.8-15.0 months). The median overall survival was not reached at the prespecified final analysis. The objective response rate was 63.9%. Serious treatment-related adverse events occurred in 38.9% of patients.
Study details: This single-center, phase 2 trial included 36 adult treatment-naive patients with advanced HCC (86.1% with high-risk features) who received lenvatinib, toripalimab, and FOLFOX-HAIC.
Disclosures: This study was supported by the National Natural Science Foundation of China, Development Planned Project in Key Areas of Guangdong Province, and the China Postdoctoral Science Foundation. The authors declared no conflicts of interest.
Source: Lai ZC, He MK, Bu XY, Xu YJ, et al. Lenvatinib, toripalimab plus hepatic arterial infusion chemotherapy in patients with high-risk advanced hepatocellular carcinoma: A biomolecular exploratory, phase II trial. Eur J Cancer. 2022;174:68-77 (Aug 15). Doi: 10.1016/j.ejca.2022.07.005
Key clinical point: First-line lenvatinib, toripalimab, and hepatic arterial infusion chemotherapy (HAIC) with oxaliplatin, leucovorin, and 5-fluorouracil (FOLFOX) is a well-tolerated and effective treatment for patients with high-risk advanced hepatocellular carcinoma (HCC).
Major finding: The progression-free survival (PFS) of 80.6% (95% CI 64.0%-91.8%) of patients was >6 months, and the median PFS was 10.4 months (95% CI 5.8-15.0 months). The median overall survival was not reached at the prespecified final analysis. The objective response rate was 63.9%. Serious treatment-related adverse events occurred in 38.9% of patients.
Study details: This single-center, phase 2 trial included 36 adult treatment-naive patients with advanced HCC (86.1% with high-risk features) who received lenvatinib, toripalimab, and FOLFOX-HAIC.
Disclosures: This study was supported by the National Natural Science Foundation of China, Development Planned Project in Key Areas of Guangdong Province, and the China Postdoctoral Science Foundation. The authors declared no conflicts of interest.
Source: Lai ZC, He MK, Bu XY, Xu YJ, et al. Lenvatinib, toripalimab plus hepatic arterial infusion chemotherapy in patients with high-risk advanced hepatocellular carcinoma: A biomolecular exploratory, phase II trial. Eur J Cancer. 2022;174:68-77 (Aug 15). Doi: 10.1016/j.ejca.2022.07.005
Key clinical point: First-line lenvatinib, toripalimab, and hepatic arterial infusion chemotherapy (HAIC) with oxaliplatin, leucovorin, and 5-fluorouracil (FOLFOX) is a well-tolerated and effective treatment for patients with high-risk advanced hepatocellular carcinoma (HCC).
Major finding: The progression-free survival (PFS) of 80.6% (95% CI 64.0%-91.8%) of patients was >6 months, and the median PFS was 10.4 months (95% CI 5.8-15.0 months). The median overall survival was not reached at the prespecified final analysis. The objective response rate was 63.9%. Serious treatment-related adverse events occurred in 38.9% of patients.
Study details: This single-center, phase 2 trial included 36 adult treatment-naive patients with advanced HCC (86.1% with high-risk features) who received lenvatinib, toripalimab, and FOLFOX-HAIC.
Disclosures: This study was supported by the National Natural Science Foundation of China, Development Planned Project in Key Areas of Guangdong Province, and the China Postdoctoral Science Foundation. The authors declared no conflicts of interest.
Source: Lai ZC, He MK, Bu XY, Xu YJ, et al. Lenvatinib, toripalimab plus hepatic arterial infusion chemotherapy in patients with high-risk advanced hepatocellular carcinoma: A biomolecular exploratory, phase II trial. Eur J Cancer. 2022;174:68-77 (Aug 15). Doi: 10.1016/j.ejca.2022.07.005
HCC: Averting post-TARE hepatic decompensation with careful patient selection
Key clinical point: Pretreatment albumin-bilirubin (ALBI) score and radiation dose on the nontumor section of the liver are independent predictive factors for post-transarterial radioembolization (TARE) hepatic decompensation in patients with hepatocellular carcinoma (HCC).
Major finding: Multivariate analysis revealed ALBI score at baseline (adjusted odds ratio [aOR] 6.425; P = .005) and radiation dose on the nontumor section of the liver (aOR 1.072; P = .011) to be independent risk factors for the development of hepatic decompensation after TARE.
Study details: Findings are from a single-center retrospective observational study that included 61 patients with HCC who underwent TARE and thereafter did (n = 17) or did not (n = 44) develop hepatic decompensation.
Disclosures: This study was conducted with no specific funding. Some authors declared serving as consultants, advisors, or speakers for various organizations.
Source: Reincke M et al. Hepatic decompensation after transarterial radioembolization: A retrospective analysis of risk factors and outcome in patients with hepatocellular carcinoma. Hepatol Commun. 2022 (Sep 5). Doi: 10.1002/hep4.2072
Key clinical point: Pretreatment albumin-bilirubin (ALBI) score and radiation dose on the nontumor section of the liver are independent predictive factors for post-transarterial radioembolization (TARE) hepatic decompensation in patients with hepatocellular carcinoma (HCC).
Major finding: Multivariate analysis revealed ALBI score at baseline (adjusted odds ratio [aOR] 6.425; P = .005) and radiation dose on the nontumor section of the liver (aOR 1.072; P = .011) to be independent risk factors for the development of hepatic decompensation after TARE.
Study details: Findings are from a single-center retrospective observational study that included 61 patients with HCC who underwent TARE and thereafter did (n = 17) or did not (n = 44) develop hepatic decompensation.
Disclosures: This study was conducted with no specific funding. Some authors declared serving as consultants, advisors, or speakers for various organizations.
Source: Reincke M et al. Hepatic decompensation after transarterial radioembolization: A retrospective analysis of risk factors and outcome in patients with hepatocellular carcinoma. Hepatol Commun. 2022 (Sep 5). Doi: 10.1002/hep4.2072
Key clinical point: Pretreatment albumin-bilirubin (ALBI) score and radiation dose on the nontumor section of the liver are independent predictive factors for post-transarterial radioembolization (TARE) hepatic decompensation in patients with hepatocellular carcinoma (HCC).
Major finding: Multivariate analysis revealed ALBI score at baseline (adjusted odds ratio [aOR] 6.425; P = .005) and radiation dose on the nontumor section of the liver (aOR 1.072; P = .011) to be independent risk factors for the development of hepatic decompensation after TARE.
Study details: Findings are from a single-center retrospective observational study that included 61 patients with HCC who underwent TARE and thereafter did (n = 17) or did not (n = 44) develop hepatic decompensation.
Disclosures: This study was conducted with no specific funding. Some authors declared serving as consultants, advisors, or speakers for various organizations.
Source: Reincke M et al. Hepatic decompensation after transarterial radioembolization: A retrospective analysis of risk factors and outcome in patients with hepatocellular carcinoma. Hepatol Commun. 2022 (Sep 5). Doi: 10.1002/hep4.2072
Postoperative adjuvant TACE efficacy in HCC depends on micronecrosis state
Key clinical point: Postoperative adjuvant transcatheter arterial chemoembolization (TACE) offers a favorable prognosis in hepatocellular carcinoma (HCC) with micronecrosis but limited efficacy against HCC without micronecrosis.
Major finding: Adjuvant TACE significantly improved the overall survival (OS; P = .004) and disease-free survival (DFS; P = .034) of patients with micronecrosis but led to a nonsignificant difference in the OS (P = .430) and DFS (P = .131) of patients without micronecrosis.
Study details: This retrospective study propensity score-matched patients who underwent curative liver resection for HCC with (n = 328) or without (n = 438) micronecrosis, with each group comprising patients who did or did not (1:1) receive adjuvant TACE after liver resection.
Disclosures: This study was supported by the National Key Research & Development Program of China and others. No information on conflicts of interest was available.
Source: Wang Y, Ge H, Hu M, et al. Histological tumor micronecrosis in resected specimens after R0 hepatectomy for hepatocellular carcinomas is a factor in determining adjuvant TACE: A retrospective propensity score-matched study. Int J Surg. 2022;105:106852 (Aug 24). Doi: 10.1016/j.ijsu.2022.106852.
Key clinical point: Postoperative adjuvant transcatheter arterial chemoembolization (TACE) offers a favorable prognosis in hepatocellular carcinoma (HCC) with micronecrosis but limited efficacy against HCC without micronecrosis.
Major finding: Adjuvant TACE significantly improved the overall survival (OS; P = .004) and disease-free survival (DFS; P = .034) of patients with micronecrosis but led to a nonsignificant difference in the OS (P = .430) and DFS (P = .131) of patients without micronecrosis.
Study details: This retrospective study propensity score-matched patients who underwent curative liver resection for HCC with (n = 328) or without (n = 438) micronecrosis, with each group comprising patients who did or did not (1:1) receive adjuvant TACE after liver resection.
Disclosures: This study was supported by the National Key Research & Development Program of China and others. No information on conflicts of interest was available.
Source: Wang Y, Ge H, Hu M, et al. Histological tumor micronecrosis in resected specimens after R0 hepatectomy for hepatocellular carcinomas is a factor in determining adjuvant TACE: A retrospective propensity score-matched study. Int J Surg. 2022;105:106852 (Aug 24). Doi: 10.1016/j.ijsu.2022.106852.
Key clinical point: Postoperative adjuvant transcatheter arterial chemoembolization (TACE) offers a favorable prognosis in hepatocellular carcinoma (HCC) with micronecrosis but limited efficacy against HCC without micronecrosis.
Major finding: Adjuvant TACE significantly improved the overall survival (OS; P = .004) and disease-free survival (DFS; P = .034) of patients with micronecrosis but led to a nonsignificant difference in the OS (P = .430) and DFS (P = .131) of patients without micronecrosis.
Study details: This retrospective study propensity score-matched patients who underwent curative liver resection for HCC with (n = 328) or without (n = 438) micronecrosis, with each group comprising patients who did or did not (1:1) receive adjuvant TACE after liver resection.
Disclosures: This study was supported by the National Key Research & Development Program of China and others. No information on conflicts of interest was available.
Source: Wang Y, Ge H, Hu M, et al. Histological tumor micronecrosis in resected specimens after R0 hepatectomy for hepatocellular carcinomas is a factor in determining adjuvant TACE: A retrospective propensity score-matched study. Int J Surg. 2022;105:106852 (Aug 24). Doi: 10.1016/j.ijsu.2022.106852.
Unresectable HCC: Atezolizumab+bevacizumab more effective in patients with good liver function
Key clinical point: Patients with unresectable hepatocellular carcinoma (uHCC) and modified albumin-bilirubin (mALBI) grade 1 or 2a show better therapeutic response to atezolizumab plus bevacizumab (ATE+BEV) treatment than those with uHCC and mALBI grade 2b or 3.
Major finding: Patients with mALBI grade 1+2a vs mALBI grade 2b+3 had a significantly higher objective response rate (26.2% vs 3.4%; P = .02) and longer median progression-free survival (10.5 vs 3.0 months; hazard ratio 2.086; P < .01) with ATE+BEV.
Study details: This retrospective observational study included 71 patients who received ATE+BEV for uHCC and had an mALBI grade of 1+2a (n = 42) or 2b+3 (n = 29).
Disclosures: No source of funding was reported. The authors declared no conflicts of interest.
Source: Tomonari T et al. Initial therapeutic results of atezolizumab plus bevacizumab for unresectable advanced hepatocellular carcinoma and the importance of hepatic functional reserve. Cancer Med. 2022 (Aug 14). Doi: 10.1002/cam4.5145
Key clinical point: Patients with unresectable hepatocellular carcinoma (uHCC) and modified albumin-bilirubin (mALBI) grade 1 or 2a show better therapeutic response to atezolizumab plus bevacizumab (ATE+BEV) treatment than those with uHCC and mALBI grade 2b or 3.
Major finding: Patients with mALBI grade 1+2a vs mALBI grade 2b+3 had a significantly higher objective response rate (26.2% vs 3.4%; P = .02) and longer median progression-free survival (10.5 vs 3.0 months; hazard ratio 2.086; P < .01) with ATE+BEV.
Study details: This retrospective observational study included 71 patients who received ATE+BEV for uHCC and had an mALBI grade of 1+2a (n = 42) or 2b+3 (n = 29).
Disclosures: No source of funding was reported. The authors declared no conflicts of interest.
Source: Tomonari T et al. Initial therapeutic results of atezolizumab plus bevacizumab for unresectable advanced hepatocellular carcinoma and the importance of hepatic functional reserve. Cancer Med. 2022 (Aug 14). Doi: 10.1002/cam4.5145
Key clinical point: Patients with unresectable hepatocellular carcinoma (uHCC) and modified albumin-bilirubin (mALBI) grade 1 or 2a show better therapeutic response to atezolizumab plus bevacizumab (ATE+BEV) treatment than those with uHCC and mALBI grade 2b or 3.
Major finding: Patients with mALBI grade 1+2a vs mALBI grade 2b+3 had a significantly higher objective response rate (26.2% vs 3.4%; P = .02) and longer median progression-free survival (10.5 vs 3.0 months; hazard ratio 2.086; P < .01) with ATE+BEV.
Study details: This retrospective observational study included 71 patients who received ATE+BEV for uHCC and had an mALBI grade of 1+2a (n = 42) or 2b+3 (n = 29).
Disclosures: No source of funding was reported. The authors declared no conflicts of interest.
Source: Tomonari T et al. Initial therapeutic results of atezolizumab plus bevacizumab for unresectable advanced hepatocellular carcinoma and the importance of hepatic functional reserve. Cancer Med. 2022 (Aug 14). Doi: 10.1002/cam4.5145